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Transfer of Inhaled Cannabis Into Human Breast Milk

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Transfer of Inhaled Cannabis Into Human Breast Milk Drugs in Pregnancy: Original Research Transfer of Inhaled Cannabis Into Human Breast Milk 10/09/2020 on BhDMf5ePHKav1zEoum1tQfN4a+kJLhEZgbsIHo4XMi0hCywCX1AWnYQp/IlQrHD3yRlXg5VZA8uapW+4JYnZFdyBruUyRNmhPZ0cMRUAMp2s81SR/9Xqtg== by http://journals.lww.com/greenjournal from Downloaded Teresa Baker, MD, Palika Datta, PhD, Kathleen Rewers-Felkins, MS, Heather Thompson, PhD, Raja R. Kallem, PhD, and Thomas W. Hale, PhD Downloaded from OBJECTIVE: To evaluate the transfer of delta-9- The estimated daily infant dose was 8 micrograms per http://journals.lww.com/greenjournal tetrahydrocannabinol and its metabolites into human kilogram per day. breast milk after maternal inhalation of 0.1 g cannabis CONCLUSION: This study documents inhaled containing 23.18% delta-9-tetrahydrocannabinol. delta-9-tetrahydrocannabinol transfer into METHODS: In this pilot pharmacokinetic study, breast the mother’s breast milk. Low concentrations of milk samples were collected from mothers who regularly delta-9-tetrahydrocannabinol were detected. The by consumed cannabis, were 2–5 months postpartum, and long-term neurobehavioral effect of exposure to BhDMf5ePHKav1zEoum1tQfN4a+kJLhEZgbsIHo4XMi0hCywCX1AWnYQp/IlQrHD3yRlXg5VZA8uapW+4JYnZFdyBruUyRNmhPZ0cMRUAMp2s81SR/9Xqtg== exclusively breastfeeding their infants. Women were delta-9-tetrahydrocannabinol on the developing anonymously recruited for the study. After discontinuing brain is unclear. Mothers should be cautious using cannabis for at least 24 hours, they were directed to cannabis during pregnancy and breastfeeding. obtain a baseline breast milk sample, then smoke a pre- (Obstet Gynecol 2018;131:783–8) weighed, analyzed, standardized strain of cannabis from DOI: 10.1097/AOG.0000000000002575 one preselected dispensary, and collect breast milk sam- ples at specific time points: 20 minutes and 1, 2, and 4 egalization of recreational cannabis use in several hours. Quantification of delta-9-tetrahydrocannabinol L states has caused growing unease in the medical and its metabolites in these collected breast milk sam- community regarding the health risks associated with ples was performed by high-performance liquid chroma- this drug, especially in pregnant and breastfeeding tography tandem mass spectrometry. women. Although cannabis is one of the most widely RESULTS: A total of eight women were enrolled. Most used phytocannabinoid drugs in the world, under- were occasional cannabis smokers and one a chronic standing of the long-term neurobehavioral effect of user. Delta-9-tetrahydrocannabinol was detected at low cannabis use, particularly in the developing brain, is concentrations at all the time points beyond time zero. limited to observational and animal data.1–7 No metabolites were detected at any time point. Delta- Cannabis sativa is most commonly smoked, 9-tetrahydrocannabinol was transferred into mother’s inhaled, or ingested orally. Cannabis smoke milk such that exclusively breastfeeding infants ingested contains more than 150 known compounds.8 an estimated mean of 2.5% of the maternal dose (the Delta-9-tetrahydrocannabinol, the most psychoactive calculated relative infant dose52.5%, range 0.4–8.7%). of the phytocannabinoids, is highly lipophilic and is stored in adipose tissues for long periods, varying from weeks to months. Once inhaled, From the Departments of Obstetrics and Gynecology and Pediatrics and the delta-9-tetrahydrocannabinol enters the plasma com- School of Pharmacy, Texas Tech University Health Sciences Center, Amarillo, on Texas; and Elephant Circle, Denver, Colorado. partment almost instantly from the pulmonary tree 10/09/2020 Each author has indicated that he or she has met the journal’s requirements for and then redistributes to highly vascularized tissues authorship. (brain, liver, and other tissues). Thus, plasma concen- Corresponding author: Thomas W. Hale, PhD, Department of Pediatrics, Texas trations are rather brief (minutes) and central nervous Tech University Health Sciences Center, 1400 Wallace Boulevard, Amarillo TX- system concentrations slightly longer (2 hours). Re- 79106; email: [email protected]. maining concentrations in the plasma are rapidly metab- Financial Disclosure – The authors did not report any potential conflicts of interest. olized in the liver. Although the elimination life is 20 36 hours, in chronic users, it might be as long as 4 days. © 2018 by American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved. Small-to-moderate secretion of tetrahydrocannab- ISSN: 0029-7844/18 inol into breast milk has been reported; however, VOL. 131, NO. 5, MAY 2018 OBSTETRICS & GYNECOLOGY 783 Copyright Ó by American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited. these reports may not adequately represent concen- research activity, complete explanation that participa- trations of tetrahydrocannabinol found in breast milk tion was voluntary, and acknowledgment that submit- today with newer commercialized cannabis products.9 ting samples implied consent. Each participant also The objective of this pilot pharmacokinetic study was received a toll-free phone number and was instructed to evaluate the transfer of delta-9- to call if she desired to review the instructions, consent tetrahydrocannabinol and its metabolites into human process, or any other questions arising concerning the breast milk at 20 minutes and at 1, 2, and 4 hours after study. maternal inhalation of 0.1 g cannabis containing Once a participant indicated interest in the pro- 23.18% of delta-9-tetrahydrocannabinol. This dose ject, she was instructed to obtain a breast milk was chosen after extensively reviewing older studies collection kit, which were made available for anony- wherein an average cannabis cigarette contained mous pickup at a local community center and approximately 0.6 g of cannabis, containing approxi- included a new glass pipe, six polypropylene bottles mately 3.55% tetrahydrocannabinol. This dose for breast milk collection, freezer packs, a shipping would amount to approximately 21.3 mg of container, a shipping label void of any identifying tetrahydrocannabinol. patient information, and complete instructions on how to proceed with the study protocol. A question- MATERIALS AND METHODS naire was included, which asked about the consump- We designed this pharmacokinetic study to measure tion of cannabis such as frequency, amount, and the transfer of inhaled cannabis into human breast preferred method, and also about any other milk. Institutional review board approval for this drug use. Information about infant age and mothers’ study was obtained from Texas Tech University body weight at the time of study was also collected. Health Sciences Center (A16-3968). The participants Participants were asked to purchase a preweighed were recruited through the InfantRisk website, flyers sample of Prezidential Kush cannabis (0.1 g with posted in Colorado community lactation social media delta-9-tetrahydrocannabinol content523.18%) at sites, and word of mouth through community-based a single specified dispensary to standardize the dose breastfeeding groups. Participants were required to be and concentration of the product being studied. They 18–45 years of age, exclusively breastfeeding, 1–6 were instructed to abstain from all cannabis consump- months postpartum, smoking cannabis while breast- tion for 24 hours before the commencement of the feeding, and to have delivered at 37 weeks of gestation study. Milk samples collected just before smoking or more. Participants selected were from Denver, Col- were considered the “zero hour” sample. Participants orado area and were willing to purchase the flower of were then to place 0.1 g of cannabis into the bowl of a specific cannabis strain from a preselected Denver the provided glass pipe, light, and inhale until con- dispensary. Exclusion criteria included ingestion of sumed (equivalent to approximately three to four hits cannabis orally, other drugs of abuse, and other med- over approximately 10–20 minutes). We also advised ications or herbal products. Pregnant patients and the presence of an assistant to ensure quality of sam- women supplementing their infants with formula or pling. Using the beginning of consumption as the start solids were also excluded from this study. The study time, breast milk samples were then collected at was open from January 2017 until October 2017. 20 minutes and 1, 2, and 4 hours after inhalation. Participants’ breast milk samples were collected Mothers were advised to pump their breasts with in polypropylene vials, which were previously deter- an electric pump, mix right and left breast milk mined to not bind tetrahydrocannabinol. Before initi- samples, and decant 1–2 ounces into the proper sam- ating the study, we tested these vials by assessing ple bottle. Samples were immediately stored in the stability of delta-9-tetrahydrocannabinol by spiking freezer after each collection. On average, 2 ounces blank milk standards with known concentrations at of breast milk were collected, frozen, and mailed to different storage conditions. Thereafter the extraction our facility overnight. No compensation was given to efficiency along with estimated concentrations was study participants. The participants collected only one determined with no concentration changes observed, set of samples. Because this study did not require which demonstrated that these collection vials were comparison between
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